EN ISO 8362-2:2024
(Main)Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2024)
Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2024)
This document specifies the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO 8362-1 and ISO 8362-4.
The dimensional requirements are not applicable to barrier-coated closures.
Closures specified in this document are intended for single use only.
NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.
Injektionsbehältnisse und Zubehör - Teil 2: Stopfen für Injektionsflaschen (ISO 8362-2:2024)
Dieses Dokument legt die Form, die Maße, die Werkstoffe, die Leistungsanforderungen und die Kennzeichnung von Stopfen für Injektionsflaschen nach ISO8362-1 und ISO8362-4 fest.
Die maßlichen Anforderungen sind nicht anwendbar auf beschichtete Stopfen.
Die Stopfen nach diesem Dokument sind nur zum einmaligen Gebrauch bestimmt.
ANMERKUNG Die Wirksamkeit, Reinheit, Beständigkeit und Sicherheit eines Arzneimittels während seiner Herstellung und Lagerung können erheblich durch die Art und Ausführung des Primärpackmittels beeinträchtigt werden.
Récipients et accessoires pour produits injectables - Partie 2: Bouchons pour flacons (ISO 8362-2:2024)
Le présent document spécifie la forme, les dimensions, le matériau, les exigences de performances et l’étiquetage des bouchons de flacons pour produits injectables faisant l’objet de l’ISO 8362-1 et de l’ISO 8362-4.
Les exigences dimensionnelles ne s’appliquent pas aux bouchons avec revêtement protecteur.
Les bouchons faisant l’objet du présent document sont à usage unique seulement.
NOTE La nature et les performances de l’emballage primaire peuvent influer considérablement sur l’efficacité, la pureté, la stabilité et la sécurité d’un produit pharmaceutique au cours de sa fabrication et de son stockage.
Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 2. del: Zapirala za viale (ISO 8362-2:2024)
Standard ISO 8362-2:2015 določa obliko, dimenzije, material, zahtevane lastnosti in etiketiranje zapiral za viale, obravnavanih v standardih ISO 8362-1 in ISO 8362‑4.
Zahteve glede dimenzij ne veljajo za zapirala s pregrado.
Zapirala, določena v standardu ISO 8362-2:2015, so namenjena le za enkratno uporabo.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2024
Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 2. del: Zapirala
za viale (ISO 8362-2:2024)
Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-
2:2024)
Injektionsbehältnisse und Zubehör - Teil 2: Stopfen für Injektionsflaschen (ISO 8362-
2:2024)
Récipients et accessoires pour produits injectables - Partie 2 : Bouchons pour flacons
(ISO 8362-2:2024)
Ta slovenski standard je istoveten z: EN ISO 8362-2:2024
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 8362-2
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2024
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN ISO 8362-2:2015
English Version
Injection containers and accessories - Part 2: Closures for
injection vials (ISO 8362-2:2024)
Récipients et accessoires pour produits injectables - Injektionsbehältnisse und Zubehör - Teil 2: Stopfen für
Partie 2: Bouchons pour flacons (ISO 8362-2:2024) Injektionsflaschen (ISO 8362-2:2024)
This European Standard was approved by CEN on 21 December 2023.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8362-2:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 8362-2:2024) has been prepared by Technical Committee ISO/TC 76
"Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical
use" in collaboration with CCMC.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by October 2024, and conflicting national standards shall
be withdrawn at the latest by October 2024.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 8362-2:2015.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 8362-2:2024 has been approved by CEN as EN ISO 8362-2:2024 without any
modification.
International
Standard
ISO 8362-2
Fourth edition
Injection containers and
2024-03
accessories —
Part 2:
Closures for injection vials
Récipients et accessoires pour produits injectables —
Partie 2: Bouchons pour flacons
Reference number
ISO 8362-2:2024(en) © ISO 2024
ISO 8362-2:2024(en)
© ISO 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
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CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 8362-2:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
5 Shape and dimensions . 2
6 Designation . 4
7 Material. 4
8 Performance requirements . . 4
8.1 General .4
8.2 Physical requirements .5
8.2.1 Hardness .5
8.2.2 Penetrability . . .5
8.2.3 Fragmentation .5
8.2.4 Self-sealing and aqueous solution tightness test .5
8.2.5 Aqueous solution tightness .5
8.2.6 Resistance to ageing .5
8.3 Chemical requirements . .5
8.4 Biological requirements .5
8.5 Particulate contamination requirements .5
9 Labelling . 5
Bibliography . 6
iii
ISO 8362-2:2024(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection, and blood
processing equipment for medical and pharmaceutical use, in collaboration with the European Committee for
Standardization (CEN) Technical Committee CEN/SS S02, Transfusion equipment, in accordance with the
Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This fourth edition cancels and replaces the third edition (ISO 8362-2:2015), which has been technically
revised. It also incorporates the Amendment ISO 8362-2:2015/Amd 1:2022.
The main changes are as follows:
— the tolerance for h mm has been modified to ±0,25 as it has been proven well in industry, is well known
and has historical relevance.
A list of all parts of the ISO 8362 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
ISO 8362-2:2024(en)
Introduction
The purpose of this document is to specify the shape and dimensions of, and the requirements for, elastomeric
closures intended for pharmaceutical use. Closures made from elastomeric materials are suitable primary
packaging materials for parenteral preparations. In order to provide seal integrity of the container closure
systems, the dimensions of the elastomeric closures have to be compa
...
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